Type 1 Diabetes MellitusPhase 1NCT01143168
Stem Cell Therapy for Type 1 Diabetes Mellitus
A Phase 1 study testing autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in people with Type 1 Diabetes Mellitus, run by Cellonis Biotechnology Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Free will taking part in the study and ability to provide written informed consent.
- Confirmed diagnosis of type I diabetes for at least 2 years
- Insulin-dependent.
- Age 18-50 years, Male/Female.
- FBG≥7.0 mmol/L, and HbAc1≥7％.
- Not pregnant or nursing.
- Negative pregnancy test.
- Fertile patients will use effective contraception.
Who cannot join
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Active infection requiring treatment.
- Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus
Read the detailed description
To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells
- Keywords
- stem cells;, diabetes mellitus;, treatment.
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cellsBiological
First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.
Measured: 1 year
Secondary outcomes (1)
Serious adverse event frequency and severity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cellonis Biotechnology Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Shi X Y, M.D., Principal investigator, Armed Police General Hospital, P. R. China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143168
- Sponsor's protocol ID
- Cellonis-CR-1.3
- Status last verified
- Jun 2010
- First submitted
- 10 Jun 2010
- Last updated
- 14 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01143168
- Acronym / sponsor ID
- Cellonis-CR-1.3
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- stem cells;, diabetes mellitus;, treatment.
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cellonis Biotechnology Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 14 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus
Detailed description
To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Free will taking part in the study and ability to provide written informed consent.
- Confirmed diagnosis of type I diabetes for at least 2 years
- Insulin-dependent.
- Age 18-50 years, Male/Female.
- FBG≥7.0 mmol/L, and HbAc1≥7％.
Key exclusion criteria (4 listed)
- Presence of acute diabetic complications in the acute stage as recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe concurrent medical condition (e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Active infection requiring treatment.
- Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cellsFirst Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously. | Biological | – |
Primary outcome
Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels.
Time frame: 1 year
Rate of reducing exogenous insulin requirement compared with baseline. Hemoglobin A1c. Fast blood glucose (FBG) and postmeal blood glucose (PBG). C-peptide levels.
1 secondary outcome
Serious adverse event frequency and severity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shi X Y, M.D. principal investigator
Armed Police General Hospital, P. R. China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in people with Type 1 Diabetes Mellitus, run by Cellonis Biotechnology Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of reducing exogenous insulin requirement; Hemoglobin A1c; Fast blood glucose (FBG) and postmeal blood glucose (PBG); C-peptide levels. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2010.